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Eligibility
for males ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in parallel into one of five patient cohorts based modality of planned or recently initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor, (B) Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive disease. Patients in cohort E will be enrolled in one of two groups: Group 1 (treatment-naïve), and Group 2 (pre-treated) (see previous section for definition). Patients enrolled in Cohorts A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy prior to initiation of next line of systemic therapy. For patients enrolled in Cohort E, group 2, patients will undergo the first tumor biopsy between 6-8 months after first dose of LHRH analogue delivered as treatment for metastatic prostate cancer.

Official Title

Precision Oncology and Molecular Targeting in Advanced Prostate Cancer: Identifying Predictive Markers of Response (The "PROMOTE" Study)

Details

After performing tumor biopsies and processing the biopsies, the researchers will perform comprehensive molecular analysis using established methods for RNA and DNA sequencing. The researchers will also collect blood samples (for circulating tumor DNA, plasma, and serum) and circulating tumor cells from participating patients. Residual paraffin-embedded blocks, frozen tissue, and blood products (serum, plasma, and circulating cells) will be stored in a repository for future testing of candidate predictive markers identified during microarray analysis. Whenever possible, the researchers will utilize a CLIA-certified laboratory to identify genetic mutations within mCRPC tumors to provide genetic information that can be returned to patient to potentially inform treatment decisions.

Following biopsy, patients will be treated per investigator discretion, with treatment corresponding to assigned patient cohort. Patients will be evaluated every 3 months for response to therapy, with serum PSA and staging scans as clinically indicated. Outcomes on treatment post-biopsy will be recorded, including maximal PSA decline, date of radiographic progression.

For cohorts A-D (mCRPC), at the time of disease progression by PCWG2 criteria, patients may undergo optional repeat tumor biopsy, along with blood collection for analysis of circulating tumor DNA and CTCs.

For cohort E, group 1, patients will undergo optional repeat tumor biopsy 6-8 months after the start of androgen deprivation therapy, along with mandatory blood collection for ctDNA and CTC analysis.

For cohort E, group 2, patients will undergo optional repeat tumor biopsy at the time of development of castration resistance as defined by PCWG2 criteria, along with mandatory blood collection for ctDNA and CTC analysis.

All patients will be followed for long term survival with every 3 month telephone calls and/or chart review.

Keywords

Prostate Cancer Castration Resistant Metastatic

Eligibility

For males ages 18 years and up

Inclusion Criteria:

  • History of histologically confirmed prostate cancer. Patients without histologically confirmed prostate cancer are eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high PSA responsive to Androgen Deprivation Therapy.)
  • Radiographic evidence of metastatic disease amenable to image-guided biopsy of a metastatic site. Soft-tissue as well as bony metastatic lesions will be considered acceptable. Patients with locally advanced disease only (where the biopsy would be of a prostatic mass) are not eligible. Biopsy of newly emerging or progressive metastases is desired and preferable to the biopsy of previously existing stable lesions whenever possible.
  • Platelets>75,000/μl
  • PT or INR and a PTT < 1.5 times the institutional ULN within 14 days prior to biopsy.
  • Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation prior to the biopsy as per usual standard of care. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the PI.
  • Patients with significant congenital or acquired bleeding disorders (eg type 3 von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible.
  • Age> 18 yrs
  • ECOG Performance status 0-2 (see appendix A)
  • Ability to understand and the willingness to sign a written informed consent.
  • Additional Inclusion Criteria for Cohorts A-D:
  • Metastatic, castration resistant disease by PCWG2 criteria, with progression on most recently applied systemic therapy prior to study registration, as defined by:
  • PSA Progression: PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart.

    and/or

  • Soft tissue progression: by RECIST v1.1 and/or
  • Bone scan progression: the appearance of ≥ 2 new lesions and/or
  • Symptomatic progression in an area of radiologically evident disease
  • Documented serum testosterone < 50 ng/dL. Patients without prior bilateral orchiectomy are required to remain on LHRH analogue for duration of study.
  • Patient is planning therapy with androgen signaling inhibitor (cohort A),immunotherapy (cohort B), chemotherapy (cohort C), or targeted therapy (cohort D).Therapeutic combinations are allowed and as treatment may fall into more than one category cohort assignment will be per PI discretion. Treatment must be planned to start within 28 days of baseline tumor biopsy.
  • Additional Inclusion Criteria for Cohort E: Metastatic hormone-naïve prostate cancer who are planning to start (Group 1) or currently receiving (Group 2) androgen deprivation therapy. The use of chemotherapy or other investigational agents is allowed but not required in both Group 1 and Group 2.

Group 1 (ADT-Naïve): Patients who have not received LHRH analogue, LHRH antagonist or any anti-androgen for metastatic disease. Prior use of androgen deprivation therapy in the(neo)adjuvant, salvage, or biochemically recurrent setting is allowed provided the last day of effective androgen deprivation was more than 12 months prior to study entry.Androgen deprivation therapy must be planned to start within 28 days of baseline tumor biopsy.

  • Group 2 (ADT Pre-Treated): Patients who have initiated androgen deprivation therapy(including LHRH agonists, antagonists and/or anti-androgens) for metastatic prostate cancer within no more than 6 months prior to study entry.

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eric Small
ID
NCT02735252
Lead Scientist
Eric Small
Study Type
Observational
Last Updated
May 2016
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